BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI

    MDR report key: 4033645 · Received August 25, 2014

    Report

    Report Number
    8030965-2014-00848
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE CONTROL UNIT DID NOT FUNCTION PROPERLY. THIS WAS ATTRIBUTED TO NORMAL WEAR. INSPECTION AND MAINTENANCE WERE PERFORMED, MOTOR AND CONTROL UNIT WERE REPLACED, AND THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(6) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MACHINE DID NOT WORK. THE BATTERY AND THE BATTERY CASE GOT VERY HOT. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513431 COLIBRI HWE SYNTHES GMBH 6402

    Patients

    Seq Age Sex Outcome Treatment
    1